The FDA has informed J.M. Smucker that the firm’s action to remove products from the marketplace is now considered a recall. The FDA based this decision on a test by the firm confirming the presence of pentobarbital in the tallow ingredient used in the affected products.

The FDA is continuing its investigation and has collected finished product samples for testing that is currently pending. While the firm and FDA testing was pending, the FDA agreed to allow the firm to withdraw products from the marketplace because it was the quickest way to remove potentially adulterated product. However, now that the firm has verified that the products contain pentobarbital, an illegal substance in pet food at any amount, the firm has agreed to continue to remove product under the voluntarily recall process. The FDA will share more information as it becomes available.

The FDA’s preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets. However, pentobarbital should never be present in pet food and products containing any amount of pentobarbital are considered to be adulterated.

The FDA is monitoring for reports of any pet illnesses associated with pentobarbital contamination in these products. Consumers can report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their local FDA Consumer Complaint Coordinators.

What is the Problem and What is Being Done About It?

The J.M. Smucker Company has initiated a withdrawal of certain canned dog food products from its Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy brands due to the potential for pentobarbital contamination. The firm is withdrawing all lots of these products that were manufactured from 2016 through the present. The FDA is issuing this notice in order to make pet owners aware of the firm’s action.

The FDA requested from J.M. Smucker a comprehensive list of withdrawn products, regardless of when they were produced. The FDA received the following list from the firm on February 16, 2018, and promptly released it to the public. The agency became aware of reports of other products also subject to withdrawal and requested clarification from J.M. Smucker, which has assured the agency that the list provided below covers all withdrawn products.

Pentobarbital is a barbiturate drug that is most commonly used in animals as a sedative, anesthetic, or for euthanasia. The FDA’s preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets. However, any detection of pentobarbital in pet food is a violation of the Federal Food, Drug, and Cosmetic Act—simply put, pentobarbital should not be in pet food . The FDA is investigating to learn the potential source and route of the contamination.

What Happens to a Pet That Eats Pet Food Containing Pentobarbital?

Pets that eat pet food containing pentobarbital can experience drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner) and inability to stand. Consuming high levels of pentobarbital can cause coma and death. However, pentobarbital present in the withdrawn products is at a low level unlikely to pose a health risk to pets.

What Do Retailers Need To Do?

Retailers should remove the withdrawn pet food from their shelves and/or website and contact the manufacturer for further instructions. If retailers have records to identify consumers who have purchased the withdrawn product, the FDA encourages those retailers to contact the consumers to alert about the product withdrawal.

What Do Consumers Need To Do?

Consumers should not feed their pets the withdrawn lots of J.M. Smucker pet food. Consumers who purchased these products should safely dispose of the cans and/or contact the firm for information about returning the product.

Pet owners who think their pets may be ill from eating food contaminated with pentobarbital should contact their veterinarians.

Who Should be Contacted?

People who think their pets have become ill after consuming pet food contaminated with pentobarbital should contact their veterinarians.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and parties involved in the investigation. The agency will update this page as more information becomes available.